Recall Z-1394-2023— Radiometer Medical ApS
Class II · Ongoing
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2023-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.. Reason: Due to potential software issue that may result in patient mix-up information..
- Recalling firm
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-08
- Firm location
- Bronshoj, N/A, Denmark
Product description
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Reason for recall
Due to potential software issue that may result in patient mix-up information.
Data sourced from openFDA. This site is unofficial and independent of the FDA.